A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients With AIDS Who Take Daily Multivitamin and Mineral Supplements

Official Title ICMJE

An Open-Label, Randomized, Three-Arm, Comparative Trial of a Caloric Supplement With Peptides and Medium-Chain Triglycerides Versus a Caloric Supplement With Whole Protein and Long-Chain Triglycerides Versus No Caloric Supplement for the Prevention of Weight Loss in Individuals With AIDS Who Take a Daily Multivitamin and Mineral Supplement

Brief Summary

To compare a caloric supplement containing peptides and medium-chain triglycerides, a caloric supplement containing whole protein and long-chain triglycerides, and no caloric supplement for the prevention of weight loss in individuals with AIDS who take a daily multivitamin and mineral supplement.

At months 0, 2, and 4, patients will be assessed for weight, body cell mass, patient-reported physical activity level, and dietary intake (by 24-hour dietary recall). At months 2 and 4, they will also be assessed for compliance with study regimen. Patients who complete their 4 month follow up visit will be provided with a 30 day supply of the caloric supplement of their choice (Peptamen or NuBasics) and a 30 day supply of the study multivitamin supplement.

Study Type ICMJE

Observational

Study Design ICMJE

Observational Model: CohortTime Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Blood collection

Sampling Method

Non-Probability Sample

Study Population

HIV-infected participants who take a daily multivitamin and mineral supplement

Condition ICMJE

HIV Infections

HIV Wasting Syndrome

Intervention ICMJE

Dietary Supplement: Multivitamin and mineral supplements

Oral tablets taken daily

Dietary Supplement: Peptamen

Solution received daily

Dietary Supplement: NuBasics

Solution or dietary bar received daily

Study Group/Cohort (s)

1

Participants will receive peptamen drinks and multivitamin and mineral supplements, taken in addition to a regular diet for 4 months

Interventions:

Dietary Supplement: Multivitamin and mineral supplements

Dietary Supplement: Peptamen

2

Participants will receive NuBasics drinks or equivalent amounts of NuBasics soups or bars and daily multivitamin and mineral supplements, taken in addition to a regular diet for 4 months

Interventions:

Dietary Supplement: Multivitamin and mineral supplements

Dietary Supplement: NuBasics

3

Participants will receive multivitamin and mineral supplements, taken in addition to a regular diet for 4 months